Behavioral Strategies to Minimize Procedural Distress During In-Office Pediatric Tympanostomy Tube Placement Without Sedation or Restraint

Lindsey L Cohen,Laura J England,Abigail S Robbertz

doi:10.1007/s10880-021-09813-0

Abstract

The purpose of this study was to evaluate behavioral strategies to minimize procedural distress associated with in-office tympanostomy tube placement for children without general anesthesia, sedation, or papoose-board restraints. 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. Mean age of children was 4.7 years old (SD = 3.18 years), with more boys (58.1%) than girls (41.9%). The cohort included 14% Hispanic or Latinx, 84.2% White, 12.6% Black, 1.8% Asian and 4.1% ‘Other’ race and ethnicity classifications. The in-office tube placement procedure included local anesthesia via lidocaine/epinephrine iontophoresis and tube placement using an integrated and automated myringotomy and tube delivery system. Behavioral strategies were used to minimize procedural distress. Anxiolytics, sedation, or papoose board were not used. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children ages 5 through 12 years. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children’s distress. Mean FPS-R score for tube placement was 3.30, in the “mild’ pain range, and decreased to 1.69 at 5-min post-procedure. Mean tube placement FLACC score was 4.0 (out of a maximum score of 10) for children ages 6 months to 4 years and was 0.4 for children age 5–12 years. Mean FLACC score 3-min post-tube placement was 1.3 for children ages 6 months to 4 years and was 0.2 for children age 5–12 years. FLACC scores were inversely correlated with age, with older children displaying lower distress. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. These data suggest that pediatric tympanostomy and tube placement can be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints.

Highlights

Myringotomy and tympanostomy tube placement for recurrent acute otitis media or chronic otitis media with effusion is the most common ambulatory pediatric surgical procedure in the USA, accounting for 24% of all pediatric (0–15 years of age) ambulatory surgeries (Hall et al, 2017)
Beyond emotional and behavioral issues, there can be complications with general anesthesia in pediatric patients, even with the brief anesthetic exposure required for a tympanostomy procedure, especially in young children (Ing et al, 2014; Wang et al, 1 3 Vol.:(0123456789)
As per the FDA-agreed upon protocol, patients were excluded from faces pain scale-revised (FPS-R) or FLACC analyses if they did not successfully complete the procedure for all indicated ears

Summary

Introduction

Myringotomy and tympanostomy tube placement for recurrent acute otitis media or chronic otitis media with effusion is the most common ambulatory pediatric surgical procedure in the USA, accounting for 24% of all pediatric (0–15 years of age) ambulatory surgeries (Hall et al, 2017). Increased risk has been noted in children up to age 4, with level of risk increasing with the amount of anesthesia exposure (Wang et al, 2014) To address these concerns, a treatment package was developed that included a medical device, customized otic anesthetic, anesthetic delivery system, and a behavioral program. Given that prior data (Zeiders et al, 2015) indicated an average procedure time of 32 min for numbing and tube placement, that the patient should remain still and in the medical chair, and that the typical target population includes very young children, pediatric agitation or distress was expected. Evidence-based strategies include providing information in non-emotive tones; using frequent and varied distraction prior to, during, and immediately following stressful procedural junctures; reinforcing cooperative and calm behavior; and highlighting and reward positive child behavior following the event to encourage positive memories (e.g., Cohen et al, 2020)

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